Ireland: Privacy In Mobile – mHealth Apps (Part I)

Technology is changing every industry and healthcare is no
exception. In the past, you might have had to join a long waiting
list to see your local GP. Today, mobile healthcare
("mHealth") allows you to download an
app, consult a practitioner by video call, access your records, get
diagnosed, monitor your symptoms remotely, manage your
prescriptions, set reminders for treatment and that's just on
your morning coffee break. mHealth may have your healthcare
covered, but who is looking after your personal data stored in
cyberspace?

What is mHealth?

mHealth refers to the practice of using mobile devices or other
wireless technology in delivering and supporting medical care
services. According to a report by Tech
Ireland, health and medical technology companies have the
highest rate of funding in the Irish technology sphere. By 2020 the
mHealth market is estimated to be worth over €60 billion,
growing at a rate of 34% annually. mHealth is effectively
transforming mobile devices into a virtual healthcare support
network that you can place in your pocket.

If mHealth is to have continued success, users must trust the
mHealth industry and how it is regulated. There are important data
privacy implications where sensitive personal data relating to
individual's health is collected and processed on such a large
scale. Data harvested from a typical mHealth app could
include health, fitness, lifestyle habits, stress levels and sleep.
To date, there has been little collaboration between EU Member
States on how to manage, organise or regulate the data protection
implications for this sector.

Origins of the Code of Conduct

The European Commission's 'eHealth Action Plan 2012-2020' sought to
distinguish between self-administration of healthcare and the
traditional provision of clinical care. It's not surprising
that the European Commission is now addressing the lack of
regulation in mHealth apps with a working set of guidelines aiming
to ensure such apps are properly regulated.

In June 2016, the European Commission proposed and submitted a
'Code of Conduct on privacy for mHealth
apps' (the "Code") to the
Article 29 Working Party, the collective body of EU data protection
authorities. Once approved, the Code will be applied in practice.
App developers can, but will not be obliged to, follow the Code.

The Code at a glance

The European Commission aims to bridge gaps in the mHealth
industry, specifically the gaps in processing sensitive data and
securing the sensitive data collected. This regulation comes in the
form of the proposed Code and is focused solely on "data
concerning health". The Code excludes regulation of any
app that deals only with users' lifestyles, such as an app that
tracks footsteps solely for measuring the user's sports
activity.

The key compliance areas highlighted by the Code are:

User consent: the need to obtain free,
specific, informed and explicit consent from the data subject to
collect and use their data.

User information: Disclosures to users before
and after installation of the app, such as the purpose for which
their data is collected and processed, identity of the developer,
storage details, rights to access/correct/delete data, and the
right to data portability.

Data retention: only storing personal data for
as long as is necessary.

2. Governance Board: comprising 6-10
members selected from the General Assembly to manage everyday
interpretation and maintenance of the Code or amendments.

3. Monitoring Body: in charge of monitoring
compliance, enforcing the Code in accordance with GDPR, reviewing
app developers' applications, and maintaining a public registry
of app developers who have met the Code's requirements.

The Code in Practice

mHealth can contribute to healthcare research and innovation,
given the large volume of data gathered. Big Data analytics can be
used to analyse unstructured data in high quantities and from
varying sources by linking data and producing statistical
information in a cost effective manner. This type of information
can be used to identify patterns and environmental factors that
will enable improved patient treatment.

While the core aim of the Code is to regulate and secure the
data gathered by mHealth apps, there is currently no guarantee that
compliance with the Code means compliance with data protection law.
Any code for mHealth will need to be consistent with the meaning
and spirit of the General Data Protection Regulation
("GDPR"), which will come into law on 25
May 2018. In our follow up article, Privacy in Mobile –
mHealth Apps (Part II), we will assess the interplay between the
proposed Code and the GDPR.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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